Kroger Specialty Pharmacy Recalls Xalkori Capsules Due to Processing Control Issues
Kroger Specialty Pharmacy is recalling Xalkori 250 mg capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or significant injuries are reported in the source text, aligning with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Xalkori 250 mg capsules (NDC 00069-8140-20, 30-day supply) due to a lack of processing controls. The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018.
The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The source text does not specify the exact number of units recalled or report any illnesses or injuries associated with the product.
Consumers who have this medication should contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Distribution
Part of a larger recall action
This product is one of 67 recalled by Kroger Specialty Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 67 products in this recall →Related recalls
Same manufacturer · Kroger Specialty Pharmacy, Inc.
See all →- HighKroger Recalls Botox Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- HighKroger Recalls Capecitabine Tablets Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Cimzia 200 mg/mL PFS Kits
FDA (Drugs) · 2018-05-16
- HighKroger Recalls Lupron Depot Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Cyclophosphamide Capsules Due to Processing Controls
FDA (Drugs) · 2018-05-16
Same hazard · processing control deficiency
See all →- ModerateDoxycycline oral suspension recalled for insanitary manufacturing conditions
FDA (Drugs) · 2022-07-13
- ModerateMasterPharm Recalls Testosterone/Anastrozole Pellets Due to Processing Control Deficiencies
FDA (Drugs) · 2020-08-05
- SevereRedline Pharmacy Recalls Ertapenem Injectable Due to Processing Control Issues
FDA (Drugs) · 2020-03-18
- SevereRedline Pharmacy Recalls Morphine Sulfate Due to Processing Control Deficiencies
FDA (Drugs) · 2020-03-18
- SevereRedline Pharmacy Recalls Vancomycin Injectable Due to Processing Control Deficiencies
FDA (Drugs) · 2020-03-18